- Details of the major baseline prognostic characteristics should be provided in
every report on a TBI study; in trials they should be differentiated per treatment
group. We also advocate the reporting of the baseline prognostic risk as determined
by validated prognostic models.
- Inclusion criteria should be as broad as is compatible with the current understanding
of the mechanisms of action of the intervention being evaluated. This will maximize
recruitment rates and enhance the generalisability of the results.
- The statistical analysis should incorporate prespecified covariate adjustment to
mitigate the effects of the heterogeneity.
- The statistical analysis should use an ordinal approach, based on either sliding
dichotomy or proportional odds methodology.
IMPACT Recommendations for Improving the Design and Analysis of Clinical Trials in Moderate to Severe Traumatic Brain Injury.
Maas AI, Steyerberg EW, Marmarou A, McHugh GS, Lingsma HF, Butcher I, Lu J, Weir J, Roozenbeek B, Murray GD.
Neurotherapeutics. 2010 Jan;7(1):127-134.